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Closing the evidence gap: Capillary high-sensitivity troponin I verification in an African population using point of
Maseti Amvuyele Ann1, Jacob Doreen1, Khoza Siyabonga1
1Department of Chemical Pathology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; National Health Laboratory Service, Johannesburg, South Africa.
Insights
Point-of-care testing using capillary blood for high-sensitivity cardiac troponin (hs-cTnI) shows good agreement with lab tests. This supports its use for rapid acute myocardial infarction (AMI) diagnosis in resource-limited areas.
Area of Science:
- Clinical Diagnostics
- Cardiovascular Medicine
- Point-of-Care Testing
Background:
- High-sensitivity cardiac troponin (hs-cTnI) assays are crucial for diagnosing acute myocardial infarction (AMI).
- Point-of-care (POC) platforms using capillary blood offer potential for faster results and improved access in resource-limited settings.
- This study assessed the performance of capillary hs-cTnI POC sampling in an African population.
Purpose of the Study:
- To evaluate the analytical performance and clinical concordance of capillary hs-cTnI POC testing against central laboratory assays.
- To determine the feasibility of using capillary blood for rapid AMI assessment in resource-limited emergency departments.
Main Methods:
- A cross-sectional method comparison study was conducted using paired capillary and venous samples from patients with suspected AMI.
- Measurements were performed on a POC platform using capillary blood and a central laboratory assay using serum and plasma.
- Agreement was assessed using Bland Altman analysis, and diagnostic concordance was determined at sex-specific 99th percentile thresholds.
Main Results:
- Capillary hs-cTnI demonstrated moderate correlation with both plasma (rs=0.788) and serum (rs=0.791) assays.
- Overall agreement at the 99th percentile threshold was high (92.1%), with substantial inter-method agreement (κ >0.75).
- The capillary method showed acceptable bias compared to the serum assay, meeting predefined criteria.
Conclusions:
- Capillary whole-blood hs-cTnI testing shows acceptable analytical agreement and high clinical concordance with central laboratory measurements.
- This supports the implementation of capillary hs-cTnI POC testing to improve rapid AMI assessment in resource-limited emergency settings.
Background:
High sensitivity cardiac troponin I (hs-cTnI) assays are central to the early diagnosis and rule-out of acute myocardial infarction (AMI). In resource-limited settings, point-of-care (POC) platforms using capillary blood may reduce turnaround time and improve access to timely decision-making. This study evaluated the performance of capillary hs-cTnI POC sampling in an African population.
Methods:
This cross-sectional method comparison study evaluated paired capillary hs-cTnI measurements obtained on POC against corresponding venous serum and plasma samples analysed on a central laboratory assay. Samples were collected from adults presenting with suspected AMI to Charlotte Maxeke Johannesburg Academic Hospital Emergency Department. Analytical verification was performed in accordance with Clinical and Laboratory Standards Institute protocols. Agreement was assessed using Bland Altman analysis. Diagnostic concordance at sex-specific 99th percentile decision thresholds and misclassification rates were determined.
Results:
In this study, 110 patients were recruited, of whom 91 were deemed eligible for analysis. Capillary hs-cTnI showed moderate correlation with both plasma (rs = 0.788; 95% CI 0.694-0.855) and serum (rs = 0.791; 95% CI 0.699-0.857). Mean bias of capillary versus plasma was -15.9% (-173% to +143%) and - 12.9% (-171% to +145%) compared with serum. Serum comparison met the predefined allowable minimum bias of 13.6%. Overall agreement at the 99th percentile was 92.1% (83/91), with substantial inter-method agreement (κ >0.75). No significant asymmetry in discordant classifications was observed (p = 0.7266; 95% CI -8.27 to 3.88).
Conclusion:
Capillary whole-blood hs-cTnI testing demonstrated acceptable analytical agreement and high clinical concordance with central laboratory measurement, supporting its implementation to enhance rapid AMI assessment in resource-limited emergency settings.
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